What Exactly is an Over The Counter Hearing Aid?

One way or the other, it looks as if Over-the-Counter hearing aids will come on the market in the not too distant future.

In March, Senators Elizabeth Warren (D. Mass), Chuck Grassley (R. Iowa), Maggie Hassan (D-N.H.), and Johnny Isakson (R-Ga. reintroduced their bipartisan Over-the-Counter Hearing Aid bill.

On May 2, the House Energy & Commerce Subcommittee held a hearing on the proposed “Over-the-Counter Hearing Aid Act,” H.R. 1652, co-sponsored by Representative Marsha Blackburn, a conservative Republican from Tennessee, and Joseph Kennedy (D. Mass).

And now the Food and Drug Administration, which regulates the sale of hearing aids, looks like it may make legislation moot. The agency is expected to make an announcement in the near future about whether or not it will approve OTC hearing aids.

What exactly is an over the counter hearing aid?

We already have a device available over the counter that corrects hearing loss. What is it if not an OTC hearing aid?  It’s a PSAP,  a Personal Sound Amplification Product, which can cost anywhere from $50 to $500.  A PSAP can only be marketed as a sound amplifier for people with normal hearing..

So what’s an OTC hearing aid? Right now it’s a concept, not a product.

An OTC hearing would probably do pretty much what a good PSAP already does, but with FDA approval. It would be a digital device, possibly with directional microphones, Bluetooth and a telecoil, and presumably it would cost $1000 or less. An OTC hearing aid could be sold direct to the consumer, without an audiologist or hearing aid dispenser involved.

An OTC hearing aid would be subject to FDA safety and efficacy standards. Most consumer activists support this initiative, as a way of getting people to correct their hearing loss. OTC hearing aids are not for people with severe hearing loss, single sided hearing loss, or hearing loss caused by a number of medical conditions. So why do I, who can never benefit from an OTC aid, support it?

Four out of five older Americans with hearing loss decide to ignore it, so clearly something needs to change. Many of these people cannot afford hearing aids or worry about stigma. More widespread hearing devices of all kinds would help with both those issues.

Competition will bring prices down. Ubiquitous use will end stigma. Lower prices, end stigma. What’s not to like?

Addendum, 9:30 pm Weds May 10: It looks like a done deal.

From Hearing Health and Technology Matters:

WASHINGTON, D.C. — Members of the American Academy of Audiology (AAA) and International Hearing Society (IHS) learned yesterday afternoon that the Over-The-Counter Hearing Aid Act legislation has now been attached to the Medical Device User Fee and Modernization Act (MDUFA). According to AAA President Ian Windmill, the MDUFA bill is considered “must-pass” legislation and is scheduled to be voted on today in the assigned Senate committee.

Because the current OTC hearing aid legislation has sponsors from both political parties, and now that it has been attached to a must-pass bill, the likelihood of passage has increased significantly.

9 thoughts on “What Exactly is an Over The Counter Hearing Aid?

  1. Another interesting post. Thank you for sharing. I have never heard of these before. I’m not even sure if we have PSAPs here in Spain.
    Not that i can benefit from the OTC hearing aid, as I have single sided deafness…But I agree that if it means lower prices and ending stigma, then is definitely worth supporting!!

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  2. My audiologist in Scarsdale sold his small practice to Phonak, one of the major suppliers, about 2 years ago. The writing was on the wall. Competition was finally coming to the hearing aid business, and the audiologist cartel, which has had a stranglehold on the American consumer, was finally coming to a close.

    But it was not the forecasted OTC aids that you’re talking about here that he was concerned about. No, it was that great dis-intermediator, the internet, that is sounding its death knell. A huge grey market has popped up in recent years that is slowly bypassing the FDA rules. The markups for aids has typically been 2 to 4 times cost, instead of the typical markup for electronic devices (eg, the typical flat screen tv is marked up less than 20%). The argument from the audiologist has always been that they bundle all thee services and ensure a perfect fit, which somehow justifies their absurd markups.

    I recently visited an audiologist who is trying to fight this inexorable trend. Among other things I needed from her was to make some small adjustments to the programming of my aids since my hearing had worsened a bit recently. She told me that her “policy” was to charge $695 per aid, a process that takes about 5 minutes. She insisted that’s pricing “policy” is consistent all over town. I knew that folks are buying their hardware on eBay or other sources and trying to get local audiologists to program them. Of course I immediately found someone who would do both aids for $200, and another web company that would do it for $99. In the meantime, Resound is working on tech to enable cloud-based programming.

    So innovation is happening in spite of the roadblocks placed by the FDA. I contend that it’s because of the FDA (and state legislators) that only 20% of folks with hearing loss use hearing aids, and the cost for those people is arguably 10 times what it should be (compare cost declines and quality improvements in virtually any other retail electronic that is NOT governed by regulations, that doesn’t have to “prove efficacy and safety”).

    Instead passing more laws and more rules, the government needs to completely get out of the hearing aid regulation business, both at the state and federal level. The instant that happens you will see incredible innovation and cost reduction, and a happier, better hearing public. Might even save some marriages.

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    • Thank you for this clear — and to the best of my knowledge — completely accurate assessment of the economics of the hearing aid business. I didn’t know about Resound’s cloud programming — that sounds great, if you have a Resound aid. Maybe the others will follow.
      You also didn’t mention the monopoly the big six have and their ability to keep prices elevated. You also didn’t mention Costco, which has audiologists on staff in many stores and is the largest retailer in the US, and sells virtually the same hearing aids by the same manufacturers at much reduced prices.
      So, as I have said repeatedly, audiologists need to rethink their business model. Sell hearing aids unbundled or at a reasonable price and then charge for each follow up visit (say, $100, if you need a quick reprogramming). Have reasonable charges for maintenance and repair for hearing aids bought on the internet or elsewhere. And then make their money by providing auditory rehabilitation, counseling on how to get the best performance from your hearing aids, teaching speech reading, selling assistive listening devices to those for whom hearing aids aren’t enough.
      The FDA bill, which includes a rider on OTC hearing aids, did go from Committee to the full Senate yesterday and is expected to pass. In my opinion, once lower costs aids are on the market, the whole pricing and fee structure will change. I”m going to post a link to an article about it separately.

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      • Katherine,
        I think there’s a mystique about the whole programming business that inculcates a sense that a highly trained audiologist must perform the programming.
        In my research I’ve encountered a few lesser known manufacturers that actually provide the software to their customers or have a technique that allows a technician to perform the programming remotely with the hearing aid attached to a local computer via USB or bluetooth. I’m no audiologist, but I am a software designer; it seems to me that some sort of software could be developed (or maybe already has) that could feed in the audiogram and automatically provide a base programming. this would probably handle 80% of the cases, which would be a huge savings. Maybe this has already been done.

        Regarding your comment about apparent cartel of six major players. You are suggesting that they have some sort of dominance bordering on collusion or some other sort of nefarious market manipulation. At the risk of getting into a debate about anti-trust, let me suggest that the FDA is solely responsible for this sort of concentration. The FDA is the generally the culprit in all sorts of areas where market participation is obstructed due to barriers to entry. I’m not intimately familiar with their hearing aid FDA regs, but I would guess that elaborate trials are required (as with ALL other medical devices and drugs) before a new device or an enhancement to an existing device can be brought to market. This is extremely costly, especially for startups and foreign companies that may not be able to afford a US staff to stay on top of the regs.

        If all the FDA control was removed, you would see hundreds of startups experimenting with new technology, undercutting the big players and eventually usurping their dominance. There are some examples of this: Eargo is a great case in point. They have an innovative device and they do not operate through audiologists or hearing aid dispensers. A pair of their aids costs under $2000, and they are rechargeable. And they are completely CIC. Interestingly they cannot ship to all 50 states due to various state regs. I’ve tried their hearing aids; they weren’t good for my hearing loss, but were wonderful otherwise, so I returned them. I’m constantly on the look out for competitors that copy their unique approach to wearability. You also have Here One from Doppler Labs, a very interesting development in the PSAP area. These technologies will eventually converge, but these companies don’t have the flexibility to experiment on a large scale with all the roadblocks in place.

        Read D.T. Armentano if you have any doubts about the effectiveness of a free market to drive costs down and provide exactly what the consumer wants or needs.

        Cheers
        Berl

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